MDR Eudamed
Data exchange WG
Roadmap and deliverables
15/11/2017
Contents
• Deliverables
• Roadmap
• Communication channels
• Q&A
GROW R3
2
Deliverables
For each module:
• Clear needs for data exchange
• -> list of needs per Actor Role with priorities
• -> Define features of the data exchange based on needs list
• -> identify limitations to be imposed on data exchange
• -> Deliverable: Business requirements Specifications +
scope statement
• Elicit requirements covering the needs
• -> identify functional requirements
• -> identify non-functional requirements (usability, reliability,
performance, scalability, supportability,…)
• -> model usage scenarios (message exchange scenarios)
• -> deliverable: Requirements Specifications
GROW R3
3
Deliverables
Based on the requirements:
• Prepare Test Cases for UAT and System Test
• -> Write business scenario test cases for User Acceptance
Test and System Test
• -> Create the requirement validation matrix
• -> Deliverable: Test Strategy containing test scenarios
GROW R3
4
Deliverables
For the different types of needs:
• Elaborate use of standards and protocols for data exchange
• COM selects technology platform(s)
• Deliverable: data exchange architecture overview document
• Defining service interfaces for data exchange
• Based on usage models
• Based on data models
• ->Deliverable: definitions of schemas and operations
• Based on technology platforms
• Defining the authentication and authorisation processes
• -> Deliverable: authentication and authorisation processes
description
GROW R3
5
Deliverables
• Implementation and testing
• Implementing solution in development environment and do
initial testing
• Write technical guidance documents for Data Exchange
Clients ( + write test client)
• Deploy solution in acceptance environment
• Have solution tested by Data Exchange Clients
• Correct and improve solution
• Perform performance and vulnerability testing
• Deployment
• Prepare deployment environment
• Deploy data exchange solution(s)
• Create end user support material
• Open the solution for use
GROW R3
6
Roadmap
• Business requirements Specifications + scope statement =
Needs, for first set of modules: review until end of 2017
• Draft Requirements specifications : in February 2018 for first
set of modules, soon after, second set of modules, to be
finalised by May at the latest for the MDCG
• Division by 1st and 2nd module set
• Schemas to be developed in line with the requirements for the
different modules, as soon as possible, based on input from
relevant working groups
GROW R3
7
Roadmap
• Implementation of data exchange in parallel with the GUI, to
be delivered soon after the GUI
• 1st Actors – only download by MS (needs to be clarified)
• 2nd UDI - Upload
• 3rd Device – Certificates –Upload
• 4th UDI, Device – Certificates Download for MS
• …
• Prepare for acceptance testing
• Deployment: only at the end, after the audit
GROW R3
8
Overall Roadmap
GROW R3
9
Data Exchange Roadmap
For 1st set of modules
GROW R3
10
Communication Channels
Wiki – being set up – CIRCABC – Functional mailbox
• Foster close collaboration and receive early feedback
• Only for members of the Eudamed working groups
Use of the Wiki
• Questions and issues will be placed by COM on the wiki
• Feedback on acceptance testing will be gathered via the wiki
• Documents from outside will be handled as before by using the
functional mailbox
• Supporting/Working documents will be stored on CIRCABC
WG Members invited to provide comments and input
GROW R3
11
Q&A
Q&A
GROW R3
12